stanford accelerated intelligent neuromodulation therapy for treatment-resistant depression (saint-trd)

Conditions: Treatment Resistant Depression

Summary: this study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. in a double-blind fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

repetitive transcranial magnetic stimulation (rtms) is an established therapy for treatment-resistant depression. the approved method for treatment is 10hz stimulation for 40 min over the left dorsolateral prefrontal cortex (l-dlpfc). this methodology has been effective in real world situations. the limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). recently, researchers have pursued modifying the treatment parameters to reduce treatment times with some preliminary successes. this study aims to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Eligibility criteria:
inclusion criteria: * male or female, 22 to 80 years of age. * able to provide informed consent. * diagnosed with major depressive disorder (mdd) and currently experiencing a major depressive episode (mde). * participants may currently be on a stable and adequate dose of ssri antidepressant therapy. participants may choose to not be on antidepressant therapy for the study duration, or to be switched from other classes to a medication from the ssri class. * participants may also have a history of intolerance to at least 2 antidepressant medications. these patients with the intolerance history will not be required to be currently taking an antidepressant medication. * participants must qualify as "moderately treatment refractory" or "high treatment refractory" using the maudsley staging method. * meet the threshold on the total hamd17 score of \>/=20 at both screening and baseline visits (day -5/-14 and day 0). * meet the threshold on the total madrs score of \>/=20 at both screening and baseline visits (day -5/-14 and day 0). * meet the threshold on the total bdi-ii score of \>/=20 at both screening and baseline visits (day -5/-14 and day 0). * in good general health, as ascertained by medical history. * if female, a status of non-childbearing potential or use of an acceptable form of birth control. the form of birth control will be documented at screening and baseline. * concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone) will be allowed if the therapy has been stable for at least 4 weeks prior to screening and if it is expected to remain stable. exclusion criteria: * female of childbearing potential who is not willing to use one of the specified forms of birth control during the study. * female that is pregnant or breastfeeding. * female with a positive pregnancy test at participation. * total hamd17 score of \< 20 at the screen or baseline visits. * total madrs score of \< 20 at the screen or baseline visits. * total bdi-ii score of \< 20 at the screen or baseline visits. * current diagnosis of a substance use disorder (abuse or dependence, as defined by dsm-iv-tr), with the exception of nicotine dependence, at screening or within six months prior to screening. * current diagnosis of axis i disorders other than dysthymic disorder, generalized anxiety disorder, social anxiety disorder, panic disorder, agoraphobia, or specific phobia (unless one of these is comorbid and clinically unstable, and/or the focus of the participant's treatment for the past six months or more). * history of schizophrenia or schizoaffective disorders, or any history of psychotic symptoms in the current or previous depressive episodes. * any axis i or axis ii disorder, which at screening is clinically predominant to their mdd or has been predominant to their mdd at any time within six months prior to screening. * considered at significant risk for suicide during the course of the study. * cognitive impairment (as noted by previous diagnoses-including dementia). * has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results. * participation in any clinical trial with an investigational drug or device within the past month or concurrent to study participation. * any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. * history of positive screening urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates. * current (or chronic) use of opiates. * history of epilepsy. * history of rtms exposure. * history of any implanted device or psychosurgery for depression. * any history of ect (greater than 8 sessions) without meeting responder criteria * history of shrapnel or metal in the head or skull. * "low treatment refractory" using the maudsley staging method. * history of cardiovascular disease or cardiac event. * history of ocd. * history of autism spectrum disorder. * history of intractable migraine * history of independent sleep disorder.

Keywords: transcranial magnetic stimulation theta burst